NCT04979234

Brief Summary

This study aims to evaluate the efficacy of an endoluminal gastric plication using an endoluminal-suturing device to improve severe OSAS in patients with a BMI above or equal to 28 kg/m² until 34.9kg/m².

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

April 13, 2021

Last Update Submit

February 23, 2023

Conditions

Sleep Apnea SyndromesOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Effectiveness on OSAS

    Proportion of patients with an apnea-hypopnea index (AHI) reduction of 50% , after the endoscopic procedure.

    6 months of follow up

Secondary Outcomes (6)

  • Effectiveness on weight loss

    6 months of follow up

  • Change of the Epworth sleepiness scale

    6 months of follow up

  • Change of respiratory parameters

    6 months of follow up

  • Change of respiratory parameters

    6 months of follow up

  • Change of respiratory parameters

    6 months of follow up

  • +1 more secondary outcomes

Study Arms (1)

Interventional

EXPERIMENTAL

Endoscopic gastric reduction

Device: Endomina- Endoscopic Sleeve GastroplastyBehavioral: Diet

Interventions

Endomina- Endoscopic Sleeve GastroplastyDEVICE

Endoscopic gastric reduction

Interventional
DietBEHAVIORAL

Multidisciplinary follow up

Interventional

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years
  • BMI between 28 to 34.9 kg/m²
  • AHI ≥ 30 events/hour
  • De novo CPAP user, installed within 2 months prior enrollment
  • Must be able to comply with all study requirements for the duration of the study, as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
  • Must be able to understand and be willing to provide written informed consent;
  • Had followed the multidisciplinary bariatric workup (blood analyses, dietician, psychologist and doctor appointments)

You may not qualify if:

  • Presence of an obesity-hypoventilation syndrome defined as a PaCO2 ≥ 45 mmHg without any other respiratory disease.
  • CPAP treatment failure defined as central sleep apnea occurrence under CPAP treatment or a residual AHI \> 5 under optimal CPAP treatment.
  • Incompliance to cPAP treatment defined as an observance to cPAP of at least 4 hours per night in average.
  • Achalasia and any other esophageal motility disorders
  • Current severe esophagitis (grade C and D based on Los Angeles Classification)
  • Current Gastro-duodenal ulcer
  • Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
  • Hypertension: uncontrolled hypertension during the last 3 months;
  • Diabetes: uncontrolled diabetes (on insulin therapy or oral therapy with Hba1c \> 10%);
  • TBWL \>5% over the last 6 months
  • Current severe renal, hepatic, pulmonary disease or cancer;
  • Current gastrointestinal stenosis or obstruction
  • Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months
  • Bariatric surgery, balloon or other endoscopic obesity-related therapy within 6 months of enrollment in this study
  • Anticoagulant therapy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesOverweightObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist (Dr M. Fernandez)

Study Record Dates

First Submitted

April 13, 2021

First Posted

July 28, 2021

Study Start

September 21, 2020

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)